Salisbury, MA, United States
Andover Healthcare Inc. recalls
2 recalls recorded since 2018, most recently on 2 April 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 April 2024
- Reason
- A packaging seal gap could impact the sterility of the product.
- Distribution
- US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1828-2024
- Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Terminated Class II Medical devices
- Recall started
- 19 June 2019
- Terminated
- 9 September 2020
- Reason
- Incomplete packaging seal of sterile product
- Distribution
- US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0179-2020, Z-0181-2020, Z-0183-2020, Z-0180-2020, Z-0184-2020, Z-0182-2020
- Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
- Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
- Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
- Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
- Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
- Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.